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CompletedNCT03139682Updated Feb 2, 2023

Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury

An observational study in Traumatic Brain Injury and Blood Brain Barrier Defect, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Nova Scotia Health Authority · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
18 Years to 85 Years
Sex
All
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Study summary

Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1 billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel interventions aimed at TBI-linked molecular targets have been successful in limiting injury and improving neurologic recovery in animal models, thus providing compelling evidence that effective intervention is possible after injury. This study proposes to investigate traumatic microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a candidate biomarker and therapeutic target in TBI.

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Conditions studied

  • Traumatic Brain Injury
  • Blood Brain Barrier Defect
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 2 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We will recruit mild (n=40), moderate (n=40) and severe (n=40) TBI patients with a TBI-linked abnormality (e.g. epidural \& subdural hematomas, subarachnoid hemorrhage, contusions). TBI will be classified by severity using the Glasgow Coma Scale (GCS); mild TBI (GCS13-15), moderate TBI (GCS 9-12), and severe TBI (GCS \<8).

Inclusion criteria

  • Age 18 - 85 inclusive
  • Clinically diagnosed TBI or evidence of TBI
  • For mild TBI, as defined by the American Congress on Rehabilitation Medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following:

    • any loss of consciousness up to 30 min
    • any loss of memory for events immediately before or after the injury as much as 24 h
    • any alteration of mental state at the time of the injury
    • focal neurologic deficits that might or might not be transient

but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a Glasgow Coma Scale score falling below 13 after 30 min.

  • For moderate TBI (GCS 9-12) and severe TBI (GCS 4-8) CT evidence of TBI-linked abnormality (intracranial lesion including traumatic SAH, contusion, extra-axial hematoma). For patients who are intubated, use best documented GCS within first 48 hours of injury.
  • Stable respiratory or hemodynamic status allowing MRI within 2-4 days of TBI as determined by the attending physician
  • Patient or substitute decision maker can provide consent

Exclusion criteria

Exclusion Criteria:

  • Pre-existing known neurologic, psychiatric disease (dementia, prior severe TBI, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor)
  • Serious infection, complications (sepsis, multilobe pneumonia, etc.) \< 4 days after TBI
  • Acute ischemic heart disease (MI or unstable angina)
  • SBP \< 100 mm Hg, DBP \< 60 mm Hg
  • MRI contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding
  • History or evidence of active malignancy
  • History or evidence of serious kidney (GFR =\<60) , heart, or liver disease
  • Pregnant or breast-feeding women
  • Inability to complete follow up visits (e.g. tourists)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Change in brain volume with blood brain barrier dysfunction

    Measurement of change in brain volume with BBBD and extent of permeability change as measured by DCE-MRI

    Time frame: At < 4, 10 ± 2, and 90 ± 10 days post-injury

  2. Change in serum biomarkers of blood brain barrier dysfunction

    Measurement of change in serum biomarkers of BBBD / neural injury (vWF, BDNF, GFAP, S100β, sTau, and sNFL)

    Time frame: At < 4, 10 ± 2, and 90 ± 10 days post-injury

  3. Change in Glasgow Outcome Scale-Extended (GOS-E)

    The GOS-E is intended to provide a general index of overall outcome that is sensitive to small but clinically relevant treatment effects in people who sustain TBI.

    Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury

  4. Change in Rivermead Post Concussion Symptom Questionnaire (RPSQ)

    The RPSQ is a 16-item self-report measure administered to individual(s) who sustained a TBI in order to measure the severity of symptoms and assess progress.

    Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury

  5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)

    PROMIS is a set of person-centered measures that evaluates and monitors domains such as physical, mental and social health in adults and children. For this study, we will utilize the following domains: depression, fatigue, and pain interference.

    Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury

  6. Change in post-traumatic epilepsy

    Screening for post-traumatic epilepsy

    Time frame: At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury

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Study locations

1 site
  • Halifax Infirmary
    Halifax, Nova Scotia B3H 3A7, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03139682
Lead sponsor
Nova Scotia Health Authority
Responsible party
Sponsor
First posted
May 4, 2017
Start date
Aug 3, 2017
Primary completion
Aug 3, 2019
Completion
Aug 3, 2021
Last update
Feb 2, 2023

Study contacts

David B. Clarke, MD, PhD
principal investigator · Nova Scotia Health Authority

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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